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NCT05011786 Clinical Trial

Open and Laparoscopic Hernia Repair. A Comparative Study

Inguinal Hernia Clinical Trial

Official title:
Is the Open Approach Superior to the Laparoscopic Hernia Repair in Children? A Retrospective Comparative Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05011786
Other study ID # 67-2019-5771
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 30, 2020

Study information
Verified date July 2021
Source University of Jordan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A retrospective comparative study in a pediatric surgery center to compare the outcomes of 2 approaches of hernia repair in the pediatric population.

Description:

The investigators reviewed the records of all children who underwent open or laparoscopic hernia repair between January 2017 and July 2019 at the pediatric surgery center at the Jordan University Hospital. Data collection included the age, gender, laterality of the hernia, the surgical approach, duration of surgery, time to discharge and time to full recovery.

Recruitment information / eligibility
Status Completed
Enrollment 155
Est. completion date December 30, 2020
Est. primary completion date July 30, 2019
Accepts healthy volunteers
Gender All
Age group 6 Months to 13 Years
Eligibility Inclusion Criteria: - All children within the age limit specified were included in the study Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• hernia repair/ligation of the hernial sac
the inguinal hernia sac is ligated using sutures at the level of internal ring throught an inguinal incision in the open group and using laparoscopic instruments in the laparoscopic group

Locations
Country Name City State
Jordan Ibrahim Khrais Amman Please Select

Sponsors (1)
Lead Sponsor Collaborator
Ibrahim Khrais

Country where clinical trial is conducted

Jordan, 

Outcome
Type Measure Description Time frame Safety issue
Primary OR duration During surgery
Primary Length of stay LOS 1 year
Primary Post operative complications 1 year
Primary Hernia Recurrence 1 year
Primary Total Cost of Surgery 1 year
Primary Cosmesis What does the parents of the children think of the cosmetic outcomes of the surgery on a scale from 1-5 1 Year
Primary Recovery Time from discharge to resuming normal daily activities year
See also
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Completed NCT05159232 - Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial N/A
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Active, not recruiting NCT04328597 - Portuguese Inguinal Hernia Cohort (PINE) Study
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